PUPIL EXPANDER

Abstract

A pupil expander is formed from a frame of shape-memory material with a covering made of elastomer. The frame is in the form of two arc-shaped sections connected together at one end to form a broken circle having free distal ends. Each arc-shaped section has an upper frame portion and a lower frame portion connected to each other at the distal ends thereof. The covering is disposed over each arc-shaped section and has a C-shaped cross section so as to form an outwardly facing groove between the upper frame portion and the lower frame portion. The pupil expander is configured to be folded in half with the grooves facing each other and straightened so as to form a cylindrical body for insertion into a tubular applicator and upon release from the applicator, the pupil expander resumes the shape of the broken circle to push the margins of the pupil wider.

Claims

1. A pupil expander comprising: a frame formed of material having shape-memory characteristics, the frame being in the form of two arc-shaped sections connected together at one end to form a broken circle with free distal ends, each arc-shaped section having an upper frame portion and a lower frame portion, and a covering over each arc-shaped section, the covering having a C-shaped cross section so as to form an outwardly facing groove between the upper frame portion and the lower frame portion, wherein the pupil expander is configured to be folded in half with the grooves facing each other and straightened so as to form a cylindrical body for insertion into a tubular applicator, and whereupon upon release from the applicator, the pupil expander resumes the shape of the broken circle.

2. The pupil expander according to claim 1, wherein the frame is formed of nitinol wire.

3. The pupil expander according to claim 1, wherein the covering is formed of an elastomer.

4. The pupil expander according to claim 1, wherein tips of the distal ends of the arc-shaped sections are bent inward toward an interior of the circle.

5. The pupil expander according to claim 2, wherein frame is constructed from a single piece of wire.

6. The pupil expander according to claim 5, wherein the connection between the two arc-shaped sections is formed by a curvature in the wire that extends toward an interior of the circle.

7. A method of inserting a pupil expander into a pupil of a patient's eye, wherein the pupil expander comprises a frame formed of material having shape-memory characteristics, the frame being in the form of two arc-shaped sections connected together to form a broken circle and having free distal ends, each arc-shaped section having an upper frame portion and a lower frame portion; and a covering over each arc-shaped section, the covering having a C-shaped cross section so as to form an outwardly facing groove between the upper frame portion and the lower frame portion on each arc-shaped portion, the method comprising: folding the pupil expander so that the grooves face each other, feeding the folded pupil expander into a tubular injector with the distal ends of the pupil expander facing an exit end of the injector, injecting the folded pupil expander into a pupil of a patient such that the distal ends contact the edge of an iris of the patient as the pupil expander unfolds, and catch the edges of the iris in the grooves of the covering until the iris expander is fully inserted into the pupil with the grooves engaging the edge of the iris, and expanding the pupil by the pupil expander returning to the broken circle shape and pulling the edge of the iris outward after the step of injecting.

8. The method according to claim 7, wherein the step of injecting comprises placing a hook around the frame between the arc-shaped portions and pushing the pupil expander out of the tubular injector by pushing the hook.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Other objects and features of the present invention will become apparent from the following detailed description considered in connection with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention.

[0013] In the drawings, wherein similar reference characters denote similar elements throughout the several views:

[0014] FIG. 1 shows a perspective view of the pupil expander according to the invention;

[0015] FIG. 2 shows a side view of the pupil expander;

[0016] FIG. 3 shows a top view of the pupil expander;

[0017] FIG. 4 shows a cut-away view of the pupil expander in a folded state inside a tubular injector;

[0018] FIG. 5 shows a cut-away view of the pupil expander as it is being pushed out of the injector at about 33% deployment;

[0019] FIG. 6 shows a cut-away view of the pupil expander as it is about 66% deployed form the injector;

[0020] FIG. 7 shows the pupil expander fully removed from the injector with the hook still engaged; and

[0021] FIG. 8 shows the pupil expander in the fully deployed position on the edge of an iris of a patient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0022] Referring now in detail to the drawings and, in particular, FIGS. 1-4 show the iris expander 10 according to the invention, which is formed of a frame 20 surrounded by a covering 30.

[0023] The frame 20 is formed of a single piece of shape-memory material, such as nitinol wire, that is shaped so as to form two arc-shaped sections 21, 22, connected by a central indented portion 23 which faces toward an interior of a broken circle formed by the arc shaped sections 21, 22. Each of the sections of the frame are bounded by an upper frame portion 24 and a lower frame portion 25 that meet at distal ends 26, 27, so as to form the shape of the broken circle when viewed from above or below.

[0024] Each of the arc shaped sections 21,22 are covered by a covering 30 which between the upper frame portions 24 and lower frame portions 25 has a C-shaped cross section so as to form an outwardly facing groove 31 between the upper frame portion 24 and the lower frame portion 25. The covering 30 can be made of any suitable material, but is preferably a material that is soft, flexible and biocompatible, such as an elastomer. Specific materials could include natural rubbers, silicone elastomers, polyurethane elastomers, and nitrile rubbers, and fluoroelastomers, among others.

[0025] In one embodiment, the tips of distal ends 26, 27 of the of the arc-shaped sections of the frame 20 are bent inward toward an interior of the circle. This prevents the wire portions from contacting the edges of the iris during deployment, to create a smoother application of the pupil expander to the iris, as only the sections covered by the elastomer coating 30 are in contact with the iris.

[0026] The application of the pupil expander 10 to an iris 100 is described below with reference to FIGS. 4-8. As shown in FIG. 4, the pupil expander 10 is folded in half at the mid-point, so that the grooves 31 are facing each other and the outer surfaces of the arc-shaped sections 21, 22 form a tubular structure when straightened. The pupil expander 10 is fed into a tubular injector 40 and the central indented portion 23, which now extends proximally, is connected to a hook element 50 within the tubular injector 40. As shown in FIGS. 5-7, the pupil expander is then gradually pushed out of the tubular injector 40 by hook element 50, which lets the arc-shaped portions 21, 22 gradually return to their original curved shape, due to the shape memory material of the frame 20. During this process, the distal ends 26, 27 contact the edge 61 of iris 60 of a patient, and slide along the edge, catching the edge in grooves 31, until the entire pupil expander 10 has exited the tubular injector 40, as shown schematically in FIG. 5 and in FIG. 8. After full deployment, hook element 50 is removed from central portion 23, and the pupil expander is left to return to its fully circular shape, pressing the edge 61 of the iris 60 wider to enlarge the pupil for cataract surgery. When the surgery is finished, the pupil expander 10 can be removed by placing hook element 50 around central portion 23 of frame 20 and pulling pupil expander 10 away from the edge 61 of iris 60.

[0027] Accordingly, while only a few embodiments of the present invention have been shown and described, it is obvious that many changes and modifications may be made thereunto without departing from the spirit and scope of the invention.